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EC approves Lutathera for GEP-NETs

September 30, 2017 12:19 AM UTC

The European Commission approved Lutathera (177-Lu-Dotatate) from Advanced Accelerator Applications S.A. (NASDAQ:AAAP) to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Specifically, the approval is for unresectable or metastatic, progressive, well-differentiated, somatostatin receptor-positive GEP-NETs in adults.

A resubmitted NDA for Lutathera to treat GEP-NETs in adults is under FDA review with a Jan. 26 PDUFA date (see BioCentury Extra, Aug. 28)...